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What the label lists and what reports show

Ethinyl estradiol and etonogestrel side effects

Ethinyl estradiol and etonogestrel's FDA label: “The most common adverse reactions (≥2%) in clinical trials were: vaginitis, headache (including migraine), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability), device-related events (e.g., expulsion/discomfort/foreign …” FAERS holds 22,084 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pulmonary embolism (3,951 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the ethinyl estradiol and etonogestrel FDA label on DailyMed (effective November 14, 2025, Organon LLC); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of using NuvaRing?

See "What is the most important information I should know about NuvaRing?" NuvaRing may cause serious side effects, including: blood clots. Like pregnancy, combination hormonal birth control methods increase the risk of serious blood clots (see following graph ), especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start using a combination hormonal birth control method or when you restart the same or different combination hormonal birth control method after not using it for a month or more. Talk with your healthcare provider about your risk of getting a blood clot before using NuvaRing or before deciding which type of birth control is right for you. […]

Source: FDA drug label, Organon LLC, effective November 14, 2025 (SPL set 55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d97), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions (≥2%) in clinical trials were: vaginitis, headache (including migraine), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability), device-related events (e.g., expulsion/discomfort/foreign body sensation), nausea/vomiting, vaginal discharge, increased weight, vaginal discomfort, breast pain/discomfort/tenderness, dysmenorrhea, abdominal pain, acne, and decreased libido.

From the label: adverse reactions, continued

The following serious adverse reactions with the use of CHCs are discussed elsewhere in the labeling. Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by CHC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (≥2%) in clinical trials were: vaginitis, headache (including migraine), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability), device-related events (e.g., expulsion/discomfort/foreign body sensation), nausea/vomiting, vaginal discharge, increased weight, vaginal discomfort, breast pain/discomfort/tenderness, dysmenorrhea, abdominal pain, acne, and decreased libido. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon USA LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Trials with a duration of 6 to 13 28-day cycles provided safety data. …

Source: FDA drug label, Organon LLC, effective November 14, 2025 (SPL set 55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d97), via openFDA; the full label on DailyMed

What do FAERS reports show?

22,084 reports list ethinyl estradiol and etonogestrel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 280 are coded as a death and 6,026 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (1,659, against a median of 505 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Pulmonary Embolism3,951
  • Deep Vein Thrombosis (named in the label)2,663
  • Inappropriate Schedule Of Drug Administration (a use or a product term, not a reaction)2,229
  • No Adverse Event (a use or a product term, not a reaction)1,589
  • Device Expulsion1,379
  • Headache (named in the label)1,180
  • Metrorrhagia1,140
  • Nausea (named in the label)1,037
  • Incorrect Drug Administration Duration1,017
  • Unintended Pregnancy951
  • Depression926
  • Anxiety (named in the label)879
  • Device Breakage (named in the label)827
  • Migraine (named in the label)822
  • Off Label Use (a use or a product term, not a reaction)724
  • Fatigue633
  • Menorrhagia633
  • Pain615
  • Thrombosis (named in the label)607
  • Product Quality Issue (a use or a product term, not a reaction)603
  • Vaginal Haemorrhage557
  • Abdominal Pain (named in the label)528
  • Pain In Extremity516
  • Dizziness (named in the label)501
  • Vomiting (named in the label)501

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ethinyl estradiol and etonogestrel: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions